comscoreLynparza Approved To Treat High-Risk, Early-Stage, HER2-Negative Breast Cancer With BRCA Mutation

Lynparza Approved To Treat High-Risk, Early-Stage, HER2-Negative Breast Cancer With BRCA Mutation

The FDA approved Lynparza to treat early-stage, HER2-negative breast cancer with a BRCA1 or BRCA2 mutation and a high risk of recurrence, which also has been previously treated with chemotherapy — either before or after surgery.
Mar 14, 2022.
 

On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved the targeted therapy Lynparza (chemical name: olaparib) to treat early-stage, HER2-negative breast cancer with a BRCA1 or BRCA2 mutation and a high risk of recurrence (the cancer coming back) after surgery. The breast cancer also must have been previously treated with chemotherapy — either before or after surgery.

Read the FDA announcement.

Doctors call treatments given after surgery adjuvant treatments. So Lynparza taken after surgery is considered an adjuvant treatment.

 

About Lynparza

Most inherited cases of breast cancer are associated with the BRCA1 and BRCA2 gene mutations. Women with a mutated BRCA1 or BRCA2 gene have up to a 72% risk of developing breast cancer by age 80 and a higher-than-average risk of developing ovarian cancer. Men with a BRCA gene mutation have a higher risk of developing both breast and prostate cancer.

DNA carries genetic information in both healthy cells and cancer cells. Cells can develop DNA damage spontaneously or from exposure to specific things in the environment (too much sun, for example) that make DNA damage more likely to happen. But cells can detect and repair damage to DNA. When a cell doesn’t detect and repair damage to DNA, the cell can become cancerous. The function of the BRCA genes is to keep breast cells growing normally and prevent any cancer growth. But a mutation in the BRCA1 or BRCA2 gene increases the risk of breast and other cancers because these gene mutations interfere with a cell’s ability to repair damaged DNA.

The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy cells and cancer cells. Research has shown that a medicine like Lynparza, which interferes with — or inhibits — the PARP enzyme, makes it even harder for cancer cells with a BRCA1 or BRCA2 mutation to fix DNA damage and survive. A PARP inhibitor can, therefore, make some cancer cells less likely to survive their DNA damage.

Lynparza is a pill taken by mouth. The recommended starting dose of Lynparza is 300 mg taken twice a day, with or without food.

 

Approval based on OlympiA results

Lynparza’s approval to treat certain early-stage breast cancers after surgery is based on results from the OlympiA study.

The study found that Lynparza after standard chemotherapy treatment for early-stage, HER2-negative breast cancer with a BRCA1 or BRCA2 mutation and a high risk of recurrence improved disease-free survival more than chemotherapy alone.

Disease-free survival is how long a person lives without the breast cancer coming back.

“Today’s approval of olaparib is great news for patients with a specific inherited form of breast cancer,” Andrew Tutt, PhD, global chair of the OlympiA trial and professor of oncology at The Institute of Cancer Research, London, and King’s College London, said in a statement.

“Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high and new treatment options are needed. OlympiA has shown that identifying a BRCA1/2 mutation in women with high-risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients.”

 

Lynparza side effects

Like almost all cancer medicines, Lynparza can cause side effects, some of the severe.

The most common side effects of Lynparza are:

  • anemia (low red blood cell counts)

  • nausea

  • fatigue

  • vomiting

  • low white blood cell counts

  • upper respiratory infections

  • cold and flu symptoms

  • diarrhea

  • bone and joint pain

  • changes in sense of taste

  • headache

  • decreased appetite

  • constipation

  • mouth sores

Lynparza also may cause serious side effects including:

  • myelodysplastic syndrome: a bone marrow failure disorder, which means your body can no longer make enough healthy blood cells

  • acute myeloid leukemia: a type of blood cancer

  • lung inflammation

Although low red and white blood cell counts are common side effects of Lynparza, they also can be symptoms of myelodysplastic syndrome or acute myeloid leukemia. Tell your doctor right away if you have the following:

  • weakness

  • fever

  • blood in your urine or stool

  • extreme tiredness

  • weight loss

  • frequent infections

  • shortness of breath

  • bruising or bleeding more easily

Additionally, although upper respiratory infections are a common side effect of Lynparza, tell your doctor right away if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, coughing, or wheezing.

Doctors check blood cell counts for people receiving Lynparza monthly, or even weekly for people who have low blood cell counts that last a long time.

 

What this means for you

If you’ve been diagnosed with early-stage, HER2-negative breast cancer with a BRCA1 or BRCA2 mutation and a high risk of recurrence, which has been treated with chemotherapy, and are making treatment decisions after surgery, you have a new option to consider.

After reviewing your unique situation and personal preferences, you and your doctor can decide if Lynparza treatment after surgery is a good option for you.

Learn more about Lynparza.

Written by: Jamie DePolo, senior editor

— Last updated on March 21, 2022, 2:28 PM

Reviewed by 1 medical adviser
 
Brian Wojciechowski, MD
Crozer Health System, Philadelphia area, PA
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